Glass delamination has developed as a quality problem for primary packaging containers
over the last years. Beside other factors the container production process can contribute to this …

Delamination of flakes in glass containers used for primary drug packaging has become a
serious quality concern in recent years. Because glass delamination typically occurs weeks/…

The pharmacopeia method for measuring the chemical durability of parenteral glass packaging
is the hydrolytic resistance test in which the vial is filled to 90% of its brimful volume as …

Even primary packaging that has been manufactured and stored properly can release
substances into the drug formulation. For this reason, pharmaceutical manufacturers are required …

… Citation: Bicker M, Müller M, Mittermüller M, Haines D, Rothhaar U, “Comparative Extractable
Studies for Injectables and Medical Devices Aligned with USP <1663> … Dr Uwe Rothhaar …

■ ABSTRACT Pharmaceutical fillers experience a variety of nuisance problems when
packaging formulations into containers such as syringes, cartridges, and vials. For liquid …

Having a primary packaging container that serves both as sterile storage compartment and
delivery device to administer drugs is the major driving force for the injectable combination …

SCHOTT pharma services provides compatibility testing for drug products in glass vials1
including a delamination screening package aligned with USP< 790> 2, USP< 1660> 3, and …

Reprinted from the June 2015 issue of Contract Pharma 89 nents and materials, like glass,
metal, plastic, rubber, adhesives or lubricants. Extractables are determined by subjecting the …

… Author ANDERSON, Olaf 1 ; SCHEUMANN, Volker 1 ; ROTHHAAR, Uwe 1 ; RUPERTUS,
Volker 1 …